Category Archives: Events

22Mar/19

FDA Shares Quality Considerations for Continuous Manufacturing

March 22, 2019Events, Latest, Regulatory, TechnologyAxendia, Continuous Manufacturing, FDA, Straight from the SourceAdministrator

A Straight from the Source Webinar

FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients.

Join FDA’s Thomas O’Connor, Ph.D. and Axendia’s Daniel R. Matlis for a live webinar.

Date and Time: April 17th at 11:00 AM ET.

We will discuss FDA’s perspective on pharmaceutical innovation and modernization including:

FDA’s draft guidance on Quality Considerations for Continuous Manufacturing
How continuous manufacturing can improve pharmaceutical manufacturing
Support of enhanced development approaches such as quality by design (QbD), process analytical technology (PAT) and models
Insights from dialogue with sponsors through the Emerging Technology Program, externally funded and internal research
Experiences from review and approval of five drug applications utilizing continuous manufacturing to date

Meet Your Trusted Sources

Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

Participation is Limited!

05Mar/19

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Disruption is on the Radar! You Must Plot a Course for Success.

March 5, 2019Business, Events, Latest, Regulatory, TechnologyAxendia, Straight from the SourceAdministrator

Webinar Available On-Demand

Disruption is on the radar! Life-Science executives must plot a course for success. That was the theme of our “Straight from the Source” webinar featuring Axendia’s President, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst, on February 20th.

Since 2005, Industry stakeholders and regulators have relied on Axendia for trusted advice on Business, Regulatory and Technology issues and trends. Due to our track-record of accurately predicting Life-Science trends, our clients often ask us to forecast what’s on the horizon.

To answer this question, we developed a Life Science radar to communicate our focus areas in the markets we service, as well as share when we predict these trends will become mainstream. Continue reading →

20Feb/19

FDA Shares a New Approach to CSV

February 20, 2019Events, Latest, RegulatoryAxendia, CSA, CSV, FDAAdministrator

A Straight from the Source Webinar

The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.

Join us for a live webinar on March 7th at 1pm Eastern. We will discuss FDA’s perspective on Computer Software Assurance (CSA) including:

FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
Applying critical thinking and risk-based principles to support technology modernization.
Identifying Acceptable Records of Assurance
Leveraging CSA to accelerate digital transformation

Meet Your Trusted Sources

Please Note: This webinar is limited to the first 100 registrants.

Can’t make the live session? No problem!

12Feb/19

A Disruptive Storm Is On The Horizon

February 12, 2019Business, Events, Latest, Regulatory, TechnologyAxendiaAdministrator

A Straight From the Source Webinar

A disruptive storm is on the Horizon and Life-Science Executives MUST plot a course to success.

Join us for a live webinar on February 20th at 11am Eastern as we discuss our insight and advise on Business, Regulatory and Technology Disruptors that are quickly approaching, including:

Artificial Intelligence/Machine Learning
Computer System Assurance
Digital Health
Digital Transformation
EU MDR
Globalization – Healthcare Markets
Industry 4.0/Manufacturing 4.0
Precision Medicine
The Internet of Medical Things (IoMT)

Meet Your Trusted Sources:

Please Note: This webinar is limited to the first 100 registrants.

04Dec/18

Veeva is Building the Life Sciences Cloud with High Speed and Velocity

December 4, 2018Business, Events, Latest, Regulatory, TechnologyAxendia, VEEVA, VeevaVaultQMSAdministrator

Veeva 2018 Summit Event Brief

By: Daniel R. Matlis, President

Introduction

“We are building the industry cloud for life sciences,” said Peter Gassner, president and CEO of Veeva during his keynote at the company’s summit in Philadelphia. “We want the industry and your company to be more efficient and effective – supporting your journey to improve and extend human life,” Gassner added.

The event brought together more than 1,400 life science professionals and experts showcasing the latest advancements for speeding product development in the industry.

Right Speed, Right Velocity

“Speed is one of Veeva’s core values,” said Gassner. I have a slightly different perspective. I took Gassner aside and explained that Axendia’s analysis of the company shows that Veeva is operating at the right velocity – not simply at high speed.

Unfortunately, our industry is ripe with examples where companies have adopted systems at breakneck speed – often to mitigate a regulatory finding, only to realize the application brought them in the wrong direction. Testament to the ‘right speed, wrong velocity approach’ are the multitude of QMS point solutions that were implemented as a reaction to 483’s and warning letters.

Veeva has been moving with speed in the right direction; working closely with their industry customers to provide mature, preconfigured out-of-the-box suites of unified applications on a single cloud platform that support key areas across the entire product lifecycle.

Veeva has become a strategic technology partner to more than 675 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is focused on customer success through its commitment to innovation and product excellence.

My interactions with industry executives at the Summit confirm that Veeva is enabling life science companies to realize the benefits of a modern, cloud-based architecture and mobile applications for critical business functions – without compromising on industry-specific functionality or regulatory compliance.

To learn how Bristol-Myers Squibb, Gilead and Sysmex America are using Veeva’s cloud for life sciences.